Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-03-30

Brief Summary

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Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality. Globally, it is responsible for 25% of all pregnancy-related deaths. PPH is unpredictable and may occur in the absence of risk factors. Tranexamic acid is an antifibrinolytic proven to reduce blood loss and transfusion requirements for various surgeries. This study aims to explore the effectiveness of tranexamic acid as an adjunct to other uterotonics before the Caesarian Section.

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Detailed Description

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Conditions

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Post Partum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group A

All women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

All women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

Group B

All women recruited to Group A will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision, as placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

All women recruited to Group B will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

Interventions

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Tranexamic acid injection

All women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

Intervention Type DRUG

Placebo

All women recruited to Group B will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. The women undergoing cesarean delivery (both elective and emergency) during the study period.
2. Willing to participate in the study after understanding the concept.

Exclusion Criteria

1. Critically ill patient.
2. Not willing to give consent to participate in the study
3. Cases diagnosed with a ruptured uterus or undergoing caesarian hysterectomy during operation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No